Two days after World Cancer Day was commemorated, a new agnostic therapy was approved in the country that allows treating 17 types of solid tumors that include, among others, breast, colon and rectum, lung, pancreas, head and neck. , brain, melanoma and sarcoma.
In Argentina, according to official data, more than 130 thousand people are detected new tumors. According to the Global Cancer Observatory (Globocan), of the International Agency for Research on Cancer (IARC), which was based on data produced by population-based cancer registries in our country, In Argentina, 130,878 new cases of cancer occurred in both sexes in 2020, the latest official figure. In other words, every four minutes a person in the country is diagnosed with cancer. The age-adjusted incidence rate was 212.4 cases per 100,000 inhabitants., turning Argentina into a country with a medium-high incidence of cancer. The most recurrent were: breast, colon and rectum, lung.
Most of the rare tumors are located in different organs and cause different symptoms in patients, who see their lives affected in a different way. However, many are united by the fact that they have the same genetic alteration of the tumor, which favors its development and growth, regardless of which organ it is present in.
In this context, there appear so-called agnostic therapies, which are drug treatments used to treat any type of cancer, regardless of where it started in the body. From today, after the approval of the National Administration of Medicines, Food and Medical Technology (Anmat) The country has “Entrectinib”, a new ‘tumor agnostic’ therapy, which was authorized for any type of solid tumor that presents specific genetic alterations (technically called ‘fusions’) in the NTRK1, 2 and 3 genes. Genetic alterations such as these are determined by molecular studies carried out in the country.
“Beyond the encouraging results that this new medication has shown, what is innovative and most original is that it is not approved for one, two or five types of cancer. It is indicated to inhibit alterations in the NTRK genes that favor the growth of some tumors, regardless of whether they are located in the brain, breast, colon or wherever. So, any patient who undergoes a molecular test and presents some NTRK gene fusion could benefit from this therapy.”, said Claudio Martín, medical oncologist, Head of Thoracic Oncology at the Alexander Fleming Institute.
the fusion of one of the three NTRK genes is present in up to 90% of rare tumors. can occur in sarcomas, glioblastoma, pancreatic, lung, breast, melanoma, head and neck, including thyroid, and colorectal cancer, among others, the company Roche reported through a statement, which blocked the treatment in the country.
The specialist explained that “although in the world we are going to the oncologist by subspecialties according to the organ affectedthe new ‘agnostic’ treatments turn this paradigm around because they make therapies be evaluated or directed by the molecular alteration of the tumor, which can appear in different organs, glands and tissues”.
The advent of these innovative, agnostic treatment options represents a fundamental shift in the way cancer is thought of: from diagnosis, to clinical trial design, to drug prioritization. A few months ago, last October, a similar therapy was presented, but from Bayer, whose drug is called Larotrectinib.
“Although the percentage of NTRK gene fusion positivity in some of the most common tumors is low, tumor agnostic therapies have an absolutely transformative potential. Science is advancing to help provide answers in the approach to complex cases of cancer. It is a new look at oncology, the product of a greater understanding of how tumors develop and grow”, added Martín.
A second mechanism on which entrectinib is also effective, it is in which another gene is altered, ROS1, present between 1 or 2% of cases of metastatic non-small cell lung cancerand Anmat also approved its use in those cases.
“Lung cancer is one of the most frequent in our country, although we already understood that it requires a very different approach depending on which gene is altered.. In all cases, it continues to be a challenge due to the existence of unsatisfied needs. In this context, new mechanisms of action such as that of this medication help to provide more and better responses”, explained Martín.
Within what is known as personalized or precision medicine, identifying the genetic alteration that the tumor presents makes it possible to determine the most appropriate treatment.
“After decoding the genome of each tumor, we know thatif we indicate targeted medication to inhibit this tumor mechanism, we will obtain better results than using traditional medications, with much less toxicity than chemotherapy, for example, and avoiding squandering resources on treatments that will be less effective or that will make the patient lose valuable and irrecoverable time”, added the oncologist.
According to Martín: “Molecular testing today should be a routine study immediately after diagnosis, because it is the key to indicating the most appropriate treatment. It is something that can be done in the country and is more accessible than before, but not all patients are in the same conditions to access it in a timely manner”.
Three clinical studies evaluated the efficacy and safety of the new medication, in patients with different types of cancer and fusions in the NTRK and ROS1 genes. Of the 150 patients with multiple cancers with NTRK fusions treated with entrectinib, in 61% the size of their tumor decreased and in 25 cases a complete response was obtained, that is, total removal of the tumor. Among those who did shrink their tumors, the median duration of response was 20 months, even in people with central nervous system metastases. The progression-free survival was 13.8 months and the overall survival was 37.12.
“These are more than encouraging results and were unthinkable a short time ago, especially since we are talking about tumors that are difficult to treat and complex diseases in advanced stages,” Martín indicated.
Besides, 67.9% of 168 non-small cell lung cancer patients with ROS1 fusions decreased the size of their tumor, including 22 patients who obtained a complete response. Median response time was 20.5 months. In addition, the median progression-free was 15.7 months and the overall survival was 47.8 months. Likewise, it was shown to reduce tumors that had metastasized in the central nervous system by more than half,6 as was the case with another study, which showed surprising, rapid and long-lasting responses, with significant reductions in the size of tumors in the central nervous system in all patients 11.
“These results on brain metastases that present this specific molecular change open up hope for many patients, Therefore, we hope that new therapies will continue to be developed in the coming years, which -alone or in combination- will help us continue advancing on the path to make cancer chronic”, closed the oncologist.
Entrectinib was licensed under special conditions and is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
It is also indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
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